Skin button with flat cable

ABSTRACT

A percutaneous connector assembly including a feedthrough assembly having a body and a plurality of electrically conductive feedthroughs extending through the body from a first end toward a second end thereof. A cable assembly having a plurality of conductors arranged side-by-side within a first plane to form a substantially flat portion thereof is included, each conductor being connected to a corresponding feedthrough of the feedthrough assembly and the flat portion extending from the body.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. Utility patent applicationSer. No. 15/446,724, filed Mar. 1, 2017, and is related to and claimspriority to U.S. Provisional Patent Application Ser. No. 62/302,459,filed Mar. 2, 2016, entitled SKIN BUTTON WITH FLAT CABLE, the entiretyof which are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

TECHNICAL FIELD

The present invention relates to a method and system for a percutaneousconnector assembly for a mechanical circulatory support device.

BACKGROUND

Many individuals suffer from severe heart failure which is characterizedby frequent hospitalizations, severe physical disability, andsignificantly shortened life spans. Heart transplantation can be alife-saving procedure and may greatly improve the quality of life of thepatient. However, donor hearts are in short supply and patients often donot survive long enough to receive this potentially life-savingprocedure.

Several medical devices have been developed as an alternative or abridge to heart transplantation that may prolong the life and evenimprove the quality of life of a patient suffering from severe heartfailure. One such device is a heart pump, commonly referred to as amechanical circulatory support device (MCSD), such as a ventricularassist device (“VAD”). VADs are typically implanted within the patientsuch that an inflow of the pump is connected to a heart's left ventricleand an outflow of the pump is connected to the patient's aorta. Duringoperation the pump may assist the left ventricle, which may besignificantly impaired, in distributing oxygenated blood throughout thebody.

Most blood pumps utilize an external controller and/or power source,which requires an electrical connection be established across thepatient's skin between the internal pump and external controller/powersource. This is typically achieved by a percutaneous connector, which isconnected to the patient's skin and includes a cable that is routedthrough the patient's body from the connector to the pump. One suchconnector is disclosed in U.S. application Ser. No. 14/738,443 filedJun. 12, 2015, the entirety of which is incorporated by reference hereinas if fully set forth herein.

Percutaneous connectors may present several challenges such as infectioncontrol and patient comfort. Traditional connectors are placed within anopening in the patient's skin, which can act as a gateway for infectiousmicroorganisms to invade the patient's body and compromise the patient'shealth, which is likely already in a state of decline. In addition,traditional connectors, which may remain attached to the patient's skinfor months or even years, are often bulky and can irritate the skin andother parts of the body disposed below the skin. As such, furtherimprovements are desirable.

SUMMARY

The present invention advantageously provides for a percutaneousconnector assembly including a feedthrough assembly having a body and aplurality of electrically conductive feedthroughs extending through thebody from a first end toward a second end thereof. A cable assemblyhaving a plurality of conductors arranged side-by-side within a firstplane to form a substantially flat portion thereof is included, eachconductor being connected to a corresponding feedthrough of thefeedthrough assembly and the flat portion extending from the body.

In another aspect of this embodiment, the body includes a side surfaceextending between and intersecting a first surface of the first end anda second surface of the second end.

In another aspect of this embodiment, the substantially flat portionextends through the side surface of the body.

In another aspect of this embodiment, the body defines an axis, whereinthe substantially flat portion extends from the body, and wherein thesubstantially flat portion defines a width orthogonally arrangedrelative to the axis of the body, the body extending through the firstand second surfaces of the body.

In another aspect of this embodiment, the cable includes a transitionportion and a round portion, the transition portion being disposedbetween the flat portion and the round portion.

In another aspect of this embodiment, the round portion is formed by theplurality of conductors being arranged within more than one plane.

In another aspect of this embodiment, the plurality of conductorsincludes a first conductor, second conductor, and third conductor, and,within the round portion of the cable assembly, the first conductor isarranged within the first plane, the second conductor is arranged in asecond plane, and the third conductor is arranged in a third plane.

In another aspect of this embodiment, the cable assembly includes ajacket forming a plurality of conduits extending along a length thereofand each conductor being disposed within a respective conduit of thejacket.

In another aspect of this embodiment, silicone oil is disposed withineach conduit between the jacket and conductors.

In another aspect of this embodiment, each conduit is connected to anadjacent conduit at an interface along the flat portion of the cableassembly, and each conduit is separated from an adjacent conduit at theinterface along the transition portion and the round portion.

In another aspect of this embodiment, a jacket of biocompatible materialis molded over the jacket along the transition portion and roundedportion of the cable assembly to maintain the separated conduits in apredetermined configuration.

In yet another embodiment, a percutaneous connector assembly includes afeedthrough assembly having a body and a plurality of electricallyconductive feedthroughs extending through the body from a first endtoward a second end thereof. A skirt connected to the body and extendingradially outwardly therefrom is included. A cable assembly having aplurality of conductors arranged side-by-side within a first plane toform a flat portion thereof is included, each conductor being connectedto a corresponding feedthrough of the feedthrough assembly and the flatportion extending from the body.

In another aspect of this embodiment, the body includes a side surfaceextending between and intersecting a first end-surface of the first endand a second end-surface of the second end.

In another aspect of this embodiment, the skirt is attached to the sidesurface of the body.

In another aspect of this embodiment, the skirt is sintered to the sidesurface of the body.

In another aspect of this embodiment, the skirt includes an innerportion having first and second surfaces converging toward each other ina radially outward direction.

In another aspect of this embodiment, the second surface extends from anedge of the body defined by the intersection of the side surface andsecond end-surface of the body.

In another aspect of this embodiment, the skirt includes a skirt edge ata radial extent thereof and a peripheral portion disposed between theinner portion and skirt edge.

In another aspect of this embodiment, the flat portion of the cableassembly extends from the body between the second end-surface andperipheral portion.

In another aspect of this embodiment, the flat portion of the cableassembly extends from the body between the first end-surface and theperipheral portion.

In another aspect of this embodiment, the flat portion of the cableassembly extends from the body and through a portion of the innerportion.

In yet another embodiment, a method of forming a percutaneous connectorassembly includes forming a jacket of dielectric material having aplurality of conduits extending along a length thereof, the plurality ofconduits being connected to one another at an interface and in a planararrangement. At least one conductor is positioned within each of theplurality of conduits. Each conduit is separated from an adjacentconduit at the interface along a portion of the jacket and forms a flatportion of connected conduits and a plurality of free lengths ofseparated conduits. The plurality of free lengths of separated conduitsare rearranged and form a round portion of conduits. Each conductor isconnected to a corresponding electrically conductive feedthrough of afeedthrough assembly.

In another aspect of this embodiment, forming a jacket of dielectricmaterial and the positioning at least one conductor within each of theplurality of conduits are performed concurrently.

In another aspect of this embodiment, forming a jacket of dielectricmaterial includes laminating the plurality of conductors with thedielectric material.

In another aspect of this embodiment, rearranging the plurality of freelengths of conduits forms a transition portion disposed between theround portion and flat portion.

In another aspect of this embodiment, connecting each conductor to acorresponding electrically conductive feedthrough of a feedthroughassembly includes connecting the conductors extending from the flatportion of conduits to the feedthroughs such that the flat portionextends from a body of the feedthrough assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

The features, aspects, and advantages of the present invention willbecome better understood with regard to the following description,appended claims, and accompanying drawings in which:

FIG. 1 is a bottom perspective view of a percutaneous connectionassembly according an embodiment of the presently disclosed inventionincluding a hermetic feedthrough assembly, cable assembly, and skirt;

FIG. 2 is a cross-sectional view of the percutaneous connection assemblyof FIG. 1 taken along a line bisecting the assembly;

FIG. 3A is a top perspective view of the hermetic feedthrough assemblyof the percutaneous connection assembly of FIG. 1 according to anembodiment of the presently disclosed invention and including an coreand a shell;

FIG. 3B is a bottom partial cutaway view of the hermetic feedthroughassembly of FIG. 2A with the shell being partially cutaway;

FIG. 4A is a schematic view of a cable assembly of the percutaneousconnection assembly of FIG. 1 according to an embodiment of thepresently disclosed invention;

FIG. 4B is a cross-sectional view of a flat portion of the cableassembly of FIG. 4A;

FIG. 4C is a cross-sectional view of a transition portion of the cableassembly taken at line C-C of FIG. 4A;

FIG. 4D is a cross-sectional view of the transition portion of the cableassembly taken at line D-D of FIG. 4A;

FIG. 4E is a cross-sectional view of a round portion of the cableassembly taken at line E-E of FIG. 4A;

FIG. 4F is a schematic cross-sectional view of a conductor of the cableassembly of FIG. 4A;

FIG. 4G is a cross-sectional view of the round portion of FIG. 4Esurrounded by a jacket;

FIG. 5A is a top perspective view of a percutaneous connection assemblyaccording another embodiment of the presently disclosed invention;

FIG. 5B is a perspective view of a core of the hermetic feedthroughassembly of FIG. 5A;

FIG. 6 is a schematic cross-sectional view of a conductor and conduitaccording to another cable assembly embodiment;

FIG. 7A is a cross-sectional view of a flat portion of a cable assemblyaccording to another embodiment of the presently disclosed invention;

FIG. 7B is a zoomed view of the flat portion of the cable assemblywithin circle A of FIG. 7A;

FIG. 8 is a side view of a skirt according to another embodiment of thepresently disclosed invention;

FIG. 9 is a side view of a skirt according to a further embodiment ofthe presently disclosed invention;

FIG. 10A is a perspective view of a skirt according to yet anotherembodiment of the presently disclosed invention; and

FIG. 10B is a side view of the skirt of FIG. 10A.

DETAILED DESCRIPTION

As used herein, the terms “about,” “generally,” and “substantially” areintended to mean that slight deviations from absolute are includedwithin the scope of the term so modified.

Referring now to the drawing sin which like reference designators referto like elements, there is shown in FIGS. 1 and 2 a percutaneousconnection assembly “10” according to an embodiment of the presentinvention. Assembly 10 generally includes a hermetic feedthroughassembly 20, cable assembly 80, and skirt 90. Percutaneous connectionassembly 10 is configured to have a low profile and provide electricalconnection between an internally implantable device and an externalcontroller and/or power supply. One type of internally implantabledevice contemplated for use with percutaneous assembly 10 is an MCSDdisclosed in U.S. Pat. No. 6,688,861, the entirety of which isincorporated by reference herein as if fully set forth herein. Anexample of an external device that can be used with the percutaneousconnection assembly can be found in U.S. Application Publication No.2010/0241223, the entirety of which is incorporated by reference hereinas if fully set forth herein. Other external and internal devices canalso be used with percutaneous connection assembly 10.

Referring now to FIGS. 3A and 3B, the feedthrough assembly 20 includes aplurality of electrically conductive feedthroughs 40 and a bodycomprised of a core 30 and a shell 50. Although the body of feedthroughassembly 20 is described throughout as being comprised of both core 30and a shell 50, it is contemplated that the body may be a monolithic orunitary body, such as a body molded from a dielectric, biocompatiblematerial over an array of feedthroughs 40, for example.

In one configuration, core 30 is made from a glass or ceramic materialthat is electrically insulating and biocompatible. Core 30 includes afirst end-surface 32 at a first end thereof and a second end-surface 34at a second end thereof. A thickness T_(c) of core 30 is defined betweenend surfaces 32 and 34 (best shown in FIG. 2). First and secondend-surfaces 32, 34 are intersected by multiple side surfaces, which maybe planar and/or convex. In some embodiments, core 30 may be cylindricaland include a single side surface extending about the entirecircumference of core 30.

Core 30 also includes a plurality of openings extending through thefirst and second end-surfaces for receipt of feedthroughs 40. Theseopenings are comprised of first and second sections. As best shown inFIG. 2, the first section intersects with first end-surface 32 and, inone configuration, has a larger diameter or cross-sectional dimensionthan the second section, which intersects with second end-surface 34. Inone configuration, the openings are arranged in side-by-side lineararrays. However, the openings can be arranged in a circularconfiguration or some other geometric configuration. In the particularembodiment depicted, there are seven openings for receipt of sevenfeedthroughs 40. However, it is contemplated that there may be more orfewer openings depending on the electrical needs of a downstreamimplantable device.

Feedthroughs 40 are elongate structures made from electricallyconductive material, such as gold, copper, silver, or platinum, forexample. Each feedthrough 40 has a first portion 42 and a second portion44. First portion 42 is generally cylindrical and has a diameter orcross-sectional dimension sized to fit within the first section of oneof the core openings. Second portion 44 has a smaller diameter orcross-sectional dimension than that of first portion 42 and is sized tofit within the second section of the core openings.

A concave dome-like surface 46 is located at a free end of first portion42 of each feedthrough 40. This helps establish a conductive interfacewith a corresponding convex, conductive surface of a cap assemblyconnectable to feedthrough assembly 20 for providing power or controlsignals to an implantable device. Such cap assembly is described in theheretofore referenced '443 application, incorporated by referenceherein. Alternatively, dome-like surfaces 46 can be convex forinterfacing with corresponding concave surfaces.

In one configuration, shell 50 is made from a biocompatible metal, suchas titanium and stainless steel, or a biocompatible polymer, such aspolyether ether ketone (PEEK), for example. Shell 50 is generallycylindrical and includes a first end-surface 52 at a first end thereofand a second end-surface 54 at a second end thereof. First and secondend-surfaces 52, 54 are substantially planar. However, such end-surfaces52, 54 can be convexly or concavely curved. A side surface 56 extendsbetween and intersects first and second end-surfaces 52, 54 to formedges 51, which may be rounded to reduce or eliminate their sharpness.One or more of these end and side surfaces 52, 54, 56 may bemanufactured to minimize microbial growth or adherence thereto. Forexample, these surfaces can be manufactured to be extremely smooth, suchas by lapping, or to have a micro-topography that is resistant tomicrobial growth, such as a Sharklet microtopography (SharkletTechnologies, Inc., Aurora, Colo.).

Shell 50 also includes a plurality of hemispherical recesses 53 (FIG.3A) formed in first end-surface 52 and arranged at predeterminedlocations for engaging complementary protrusions of a cap assembly tohelp align the cap assembly with feedthrough assembly 20. In addition,magnets 60 are embedded into first end-surface 52 to facilitate lockingengagement with a cap assembly that has complementary magnets.

Further, shell 50 includes a first opening 55 that extends through shell50 from first end-surface 52 to second end-surface 54 and is sized andshaped to receive core 30 therein. In the depicted embodiment, shell 50has a thickness T_(S) defined between first and second end-surfaces 52,54 that is greater than the thickness T_(I) of core 30. As such, firstopening 55 is generally longer than core 30 is thick. Shell 50 alsoincludes a second or transverse opening 57 which extends through sidesurface 56 and is in communication with first opening 55. In oneconfiguration, second opening 57 is formed as a shallow slot that issized to receive cable assembly 80, which is described in further detailbelow.

In the assembled feedthrough assembly 20, feedthroughs 40 are disposedwithin corresponding core openings. The differences in diameter betweenthe first and second sections of the core openings creates shoulders forfirst portions 42 of feedthroughs 40 to rest upon (best shown in FIG.2). First portions 42 of feedthroughs 40 are positioned within the coreopenings such that they are flush with first end-surface 32 of core 30.In such embodiment, concave domed-surfaces 46 are recessed beneath firstend-surface 32 of core 30, as best shown in FIGS. 2 and 3A. At theopposite end of core 30, second portions 44 of feedthroughs 40 extendfrom second end-surface 34, as shown in FIG. 2.

Core 30 is disposed within first opening 55 such that first end-surfaces52 and 32 of shell 50 and core 30, respectively, are aligned orcoplanar. Additionally, second end-surface 32 of core 30 terminatesbefore reaching the end of first opening 55, which forms a cavity nearthe second end of shell 50 (best shown in FIG. 2). Second portions 44 offeedthroughs 40 extend into this cavity. Core 30, feedthroughs 40, andshell 50 are joined together to form a hermetic seal at theircorresponding boundaries, which can be performed by metal-ceramicbrazing or metal-glass joining as is known in the art. Such hermeticjoining helps prevent microorganisms from traveling through feedthroughassembly 20 into a patient when implanted.

FIGS. 4A-4F depict cable assembly 80 according to an embodiment of thepresent disclosure. Cable assembly 80 includes a plurality of insulatedconductors 81 arranged into a flat portion 82, transition portion 84,and round portion 86 of the cable assembly. Each conductor 81 is anelectrically conductive wire 83 surrounded by insulation 85, which ismade from a dielectric, biocompatible material such as polyurethane,silicone, nylon, as best shown in FIG. 4F.

FIG. 4B illustrates a cross-section of flat portion 82 of cable assembly80. Conductors 81 along flat portion 82 are joined together in aside-by-side configuration such that they are each arranged in a singleplane. The insulation 85 covering conductor 81 is joined to theinsulation covering the next adjacent conductor 81 at an interface by.This can be achieved, for example, by extruding a plurality of wires 81with insulation 85, by laminating wires 81 with insulation 85 into theillustrated flat configuration, or by an adhesive disposed at theinterfaces between adjacent conductors. In the depicted embodiment,there are seven conductors 81 a-d. However, it should be understood thatmore or less conductors 81 may be utilized depending on the electricalneeds of the downstream implantable device. In this seven conductorarrangement, a center conductor 81 d is flanked on each side by threeconductors, namely a first flanking conductor 81 a, second flankingconductor 81 b, and third flanking conductor 81 c. As indicated above,each of these conductors 81 a-d are connected to an adjacent conductorand are arranged in a first plane.

FIGS. 4C and 4D illustrate cross-sections taken at different locationsalong transition portion 84 of cable assembly 80. Transition portion 84is that portion of cable assembly 80 along which there is a gradualchange in the configuration of conductors 81. Conductors 81 along bothtransition portion 84 and round portion 86 are separated from each otheralong their length so that they can be reconfigured into round portion86. In other words, conductors 81 are disassociated from each other by,for example, separating a conductor 81 from an adjacent conductor 81 attheir interface so as to form free-lengths of conductors 81 that arereconfigurable. However, this separation of conductors 81 terminates atflat portion 82 where conductors 81 remain attached to one another.

As shown, within transition portion 84, first flanking conductors 81 aremain in the first plane while second flanking conductors 81 b aregradually moved below the first plane into a second plane, and thirdflanking conductors 81 c are gradually moved above into a third plane.The movement of second and third flanking conductors 81 b, 81 c awayfrom the first plane allows first flanking conductors 81 a to moveinwardly toward center conductor 81 d (best shown in FIGS. 4C and 4D).At the end of transition portion 84, conductors 81 a-d are closelyarranged into a round configuration, which is illustrated in FIG. 4E.The outline of the flat portion 82 is shown in each of FIGS. 4C-4E forcomparison.

Along round portion 86, first flanking conductors 81 a are locatedwithin the first plane along with center conductor 81 d, the secondflanking conductors 81 b are located in a second plane offset from thefirst plane, and the third flanking conductors 81 c are located in athird plane offset from the first and second planes. Such planes, incross-section, are substantially parallel.

Conductors 81 a-d desirably are held together to maintain the roundedconfiguration of round portion 86. For example, a jacket 87 can beapplied over round portion 86. Such jacket 87 can also extend over partor all of transition portion 84. Jacket 87 may be made of pottingmaterial formed over conductors 81, such as by a two shot process, toallow conductors 81 to be precisely located within the molded material.Alternatively, jacket 87 can be a preformed sleeve of biocompatiblematerial placed about round portion 86. Desirably, the arrangement usedto hold the conductors to one another within round portion 86 allowsconductors 81 to move slightly relative to one another and relative tojacket 87 to facilitate flexing of round portion 86. To further enhanceflexibility of round portion 86, a lubricant (not shown) may be providedon the outer surfaces of insulation layers 85 of the individualconductors. Also, jacket 87 desirably is formed from a relatively softmaterial to enhance flexibility. If a potting material is used to formjacket 87, the potting material and the insulation of the individualconductors may be selected so that the potting material does not adhereto insulation 85.

In a method of making cable assembly 80, a plurality of wires 83 arelaminated from two sides with insulation 85 to form flat portion 82 ofcable assembly 80. Alternatively, insulation 85 is molded, extruded orotherwise formed so as to form connected conductors 81 a-d such thateach conductor 81 a-d is strippable from an adjacent conductor. Theresulting assembly includes a length of flat cable comprised of aplurality of conductors 81 arranged side-by-side in a flatconfiguration.

Each conductor 81 a-d is stripped or disassociated from one or moreadjacent conductors along the length of the flat cable such that theassembly includes a flat portion 82 of connected conductors 81 andfree-lengths of separated conductors extending from flat portion 82. Thefree-lengths of separated conductors 81 are then rearranged to have around configuration as previously described. However, it should beunderstood that other arrangements resulting in a round portion 86 arepossible and may differ depending on the number of conductors 81 beingrearranged. Once conductors 81 are rearranged, a jacket may be appliedto the transition and round portions 84, 86 to maintain them in suchconfiguration.

Crimps 70 (FIG. 2), or swages (not shown), can be attached tocorresponding conductors 81 at an end of flat portion 82. This may beperformed by separating conductors 81 at their interface a lengthsufficient to allow a crimp 70 to be applied to an end of each conductor81. Each crimp 70 is a hollow cylindrical structure that is made fromconductive material, such as platinum-iridium alloy. Each crimp 70 has abore extending along the axis of the cylinder and sized to receive thewire 83 of one conductor 81. Each crimp 70 also has a transverse openingwhich is sized to receive feedthroughs 40. Feedthroughs 40 can be weldedor otherwise attached to crimps 70 such that crimps 70 extendorthogonally relative to the feedthroughs and toward second opening 57of shell 50 (best shown in FIGS. 2 and 3B). Crimps 70 can be used toattach cable assembly 80 to feedthrough assembly 20 without the need forsolder.

Skirt 90 is generally disc shaped and includes an inner portion 92 and aperipheral portion 96 (best shown in FIGS. 1 and 2). Inner portion 92includes first and second surfaces 94 a, 94 b that, in oneconfiguration, are conical and converge toward each other in a radiallyoutward direction away from side surface 56 of shell 50. However, insome embodiments surfaces 94 a and 94 b can be dome-shaped or some otherconvex shape rather than conical. Surfaces 94 a and 94 b intersectperipheral portion 96, which extends from inner portion 92 to an edge 98of skirt 90. Edge 98 defines a radial extent of skirt 90. Peripheralportion 96 has a uniform thickness along its radial extent. The conicalgeometry of inner portion 96 provides rigidity near feedthrough assembly20 to help prohibit percutaneous assembly 10 from being pulled out fromthe patient's skin. The geometry of peripheral portion 96 providesflexibility farther from feedthrough assembly 20 to help provide patientcomfort.

In the final assemblage of the percutaneous assembly 10, skirt 90 may beformed and connected to side surface 56 of shell 50 by sintering ormolding a flowable material, such as a biocompatible polymer or titaniumpowder, for example, which facilitates a strong connection between skirt90 and feedthrough assembly 20 as well as closing off potentialpassageways for microorganisms. In addition, skirt 90 may be formed tohave porous or roughened surfaces to facilitate tissue ingrowth. Asshown in FIGS. 1 and 2, inner portion 92 is connected to side surface 56of shell 50 such that second surface 94 b extends from an edge 51 orvery near edge 51 of shell 50. This smooths edge 51, helping to reduceor eliminate patient discomfort that can be caused by edge 51 rubbingagainst soft tissue disposed beneath the patient's skin. In addition,the thickness of skirt 90 at the interface between shell 50 and skirt 90is greater than at edge 98 of the skirt 90. Such thickness at theshell-skirt interface helps reduce shear stress at the interface andprevent disassociation of skirt 90 from feedthrough assembly 20 duringuse.

Furthermore, transverse opening 57 extends through shell 81 and innerportion 92 of skirt 90 between second end-surface 54 and peripheralportion 96. As mentioned above, core 30 is thinner than sleeve 50. Thus,when core 30 is disposed within opening 55 of sleeve 50, a void isformed between end-surface 34 of core 30 and the second end of sleeve50. As shown in FIG. 2, this void is in communication with transverseopening 57, and crimps 70 are disposed within the void where they areconnected to feedthroughs 40 and extend therefrom in a substantiallyorthogonal direction. Cable assembly 80 extends through transverseopening 57 into the void where each conductor is connected to acorresponding feedthrough 40 via crimps 70. The void may be filled witha biocompatible potting material to help insulate such connections andto isolate the connections from tissues within the body. This pottingmaterial desirably extends to jacket 87 covering the round portion ofcable assembly 80 so that the jacket and potting material form acontinuous protective covering. Thus, as illustrated in FIG. 2, cableassembly 80 extends from feedthrough assembly 20 between secondend-surface 54 of shell 50 and peripheral portion 96 of skirt 90. Inother embodiments, transverse opening 57 can be situated such that cableassembly extends from feedthrough assembly 20 between first surface 52and peripheral portion 96, or through skirt 90 such that cable assemblyextends from edge 98.

The portion of cable assembly 80 that connects to and extends away fromfeedthrough assembly 20 is flat portion 82. Flat portion 82 is arrangedso that the width W_(F) of flat portion 82 is orthogonal to thethickness of feedthrough assembly 20, which is the same asshell-thickness T_(S). The thickness of feedthrough assembly 20 is largerelative to the thickness of flat portion 82 of cable assembly 80. Thus,in the described connection between cable assembly 80 and feedthroughassembly 20, cable assembly 80 occupies a minimal amount of thefeedthrough assembly's thickness. This configuration allows for aminimal amount of percutaneous assembly 10 to be disposed beneath thepatient's skin and for the overall structure of percutaneous assembly 10to be compact. In other words, the flatness of cable 80 and its exitlocation from feedthrough assembly 20 proximate to an end thereof helpsminimize the amount of material positioned beneath a patient's skin whenimplanted.

A method of implanting percutaneous connection assembly 10 inconjunction with an implantable device, such as the MCSD discussedabove. The implantable device is electrically connected to percutaneousconnection assembly 10 at an end of round portion 86 of cable assembly80. Such connection may be made during the manufacturing process orintraoperatively. For example, a separable connector (not shown) may belocated at the end of round portion 86 remote from feedthrough assembly20. During the implantation procedure, the separable connector can becoupled to a corresponding connector on the implantable device wheneverit is desirable.

A surgical procedure may be performed to gain access to the patient'sthoracic cavity or other site where the implantable device is to beplaced. The implantable device is connected to the heart or other targetorgan, as is known in the art. An incision is made in the patient's skinat the location where percutaneous connection device 10 is to be placedas, for example, in the skin covering the abdomen. A hole is formed inthe skin adjacent the incision. Feedthrough assembly 20 is placedthrough the incision, so that skirt 90 is disposed beneath the skin andso that the first end of feedthrough assembly 20 projects out of theskin through the hole. Cable assembly 80 is routed through the patient'sbody towards the implantable device. For example, round portion 86 ofcable assembly 80 may be pulled through a tunnel beneath the skin. Theend of round portion 86 remote from feedthrough assembly 20 is connectedto the implantable device. This connection may be a direct connection ora connection through one or more intermediate elements. For example,cable assembly 80 may connect with one end of an intermediate cable, andthe other end of the intermediate cable may be connected to theimplantable device.

As round portion 86 of cable assembly 80 is routed through the patient'sbody, it flexes to follow the desired routing through anatomicalstructures. The flexibility in multiple dimensions of round portion 86is facilitated by its round configuration. Moreover, because theindividual conductors are free to move relative to one another withinround portion 86, flexibility is enhanced. To further enhanceflexibility, a lubricant, such as an oil, can be applied on theinsulators of the individual conductors. An external device may includea cap assembly, such as the cap assembly described in the heretoforereferenced '443 application. Such cap assembly may include electricalcontacts corresponding to feedthroughs 40 and magnets corresponding tomagnets 60. The cap assembly, and electrical contacts thereof, may beconnected to the portion of the feedthrough assembly 20 protruding fromthe incision in order to electrically connect the external device topercutaneous connection assembly 10 and consequently to the implantabledevice. The magnetic attraction of magnets 60 and the magnets of the capassembly help hold the cap in place.

When placing feedthrough assembly 20 through the incision, feedthroughassembly 50 is pushed through the incision until skirt 90 abuts aninternal layer of the skin. Over time, tissue may grow into the porousor rough surfaces of skirt 90 helping to secure feedthrough assembly tothe patient's skin. The geometry of inner portion 92 of skirt 90, whichis thicker than that of peripheral portion 98, provides sufficientrigidity around the incision to help prevent feedthrough assembly 20from being pulled through the incision. However, the relatively flexibleperipheral portion 96 provides sufficient flexibility of skirt 90 moredistant from the incision to minimize patient discomfort. The connectionof skirt 90 to feedthrough assembly 20 adjacent the second end thereofof minimizes the amount of feedthrough assembly 20 extending beneath thepatient's skin which can help reduce or eliminate irritation that may becaused by edge 51.

Feedthrough assembly 20 is also placed through the incision such thatwidth W_(F) of flat portion 82 of cable assembly 80 extends fromfeedthrough assembly 20 in a substantially parallel direction relativeto the patient's skin. As flat portion 82 extends from the incision,flat portion 82 curves away from the skin and transitions to roundportion 86 which extends toward the heart and implantable device.Although, flat portion 82 is substantially flexible in only onedimension, such multidimensional inflexibility is accounted for by themultidimensional flexibility of round portion 86 of cable assembly 80.This allows the flatness of flat portion 82 help minimize the amount offeedthrough assembly 20 extending beneath the patient's skin whilemaintaining multidimensional flexibility of cable assembly 80 beneficialin the implantation of the implantable device and percutaneous assembly10.

Other alternative embodiments of the aforementioned devices andassemblies are contemplated. FIGS. 5A and 5B depict a percutaneousconnector assembly 110 according to another embodiment of the presentdisclosure. Connector assembly 110 is similar to assembly 10 in thatassembly 110 includes a skirt 190 connected to a feedthrough assembly120 and a flat/round cable assembly 180 extending therefrom. However,assembly 110 differs with regard to core 130. As depicted, core 130 isthinner than core 30 discussed above with reference to FIGS. 1 and 2.The reduced thickness of core 130 is illustrated by the transparentportion in FIG. 5B. When core 130 is inserted into shell 150, firstend-surface 132 of core 130 is recessed beneath first end-surface 152 ofshell 150. This forms a cavity, which can be filled with potting epoxyor silicone. When assembled, first portions 142 of feedthroughs 140extend from first end-surface 132 of core 130. The first portions 142desirably are not fully covered by the potting, so that they remainexposed for contact with mating conductors on a cap. This embodiment canhelp address potential corrosion issues, such as when gold feedthroughsare brazed to a ceramic core. This embodiment can also help reduce theoverall weight of feedthrough assembly 120 or for adaption to aparticular plug of an external device.

In the embodiment discussed above, the insulation layer 85 of eachconductor 81 (FIG. 4F) forms a conduit enclosing only the wire 83 of theconductor. These conduits are connected together to form flat portion 82and rearranged to form round portion 86. (FIGS. 4A-4G). However, asshown in FIG. 6 each conductor 81, including the insulation layer 81 andwire 83 can be disposed within a lumen 89 of a larger conduit 88. Suchconduit 88 can be made from materials similar to insulation 85. Suchconduits 88 can be arranged into the flat, transition, and roundportions 82, 84, 86 in the same manner described above. Thus, in such aconstruction 80′, each conduit 88 would be connected to an adjacentconduit 88 along flat portion 82 and separated and reconfigured intoround portion 86. Silicone oil or another lubricant can be disposedwithin lumen 89 between conductor 81 and conduit 88 to help reducefriction therebetween.

FIGS. 7A and 7B depict an alternative embodiment cable assembly 280which can also be configured to have both round and flat portions. Muchlike cable assembly construction 80′, assembly 280 includes a pluralityof conduits 288 attached to one another in a flat configuration.However, cable assembly 280 differs in that one or more of conduits 288defines a lumen 289 configured to receive multiple conductors 281,therein, rather than a single conductor. For example, in the depictedembodiment, three conduits 288 a-c having ovular shaped lumens 289 a-cis comprised of a center conduit 288 a, and first and second flankingconduits 288 b-c. The center conduit 288 a, in one configuration, has awider lumen 289 a than adjacent first and second flanking conduits 288b-c. As such, center conduit 288 a can receive three conductors 281, andfirst and second flanking conduits 288 b-c can each receive twoconductors. In a flat configuration, shown in FIG. 6B, conduits 288 a-care arranged side-by-side in a first plane. In addition, the conductorsdisposed within each one of the conduits 288 a-c are arrangedside-by-side in the first plane.

Conduits 288 a-c can be separated along a portion of their length andrearranged to form a round portion in addition to a flat portion. Thiscan be achieved by separating conduits 288 a-c along a portion of cableassembly 280 and rearranging flanking conduits 288 b-c so that centerconduit 288 a and the conductors 281 disposed therein, remains in thefirst plane and so that first and second flanking conduits 288 b-c, andtheir respective conductors disposed therein, are disposed in second andthird planes, respectively. Owing to the smaller widths of flankingconduits 288 b-c, the general profile of this configuration is round,rather than flat.

Although cable assembly 280 is described as having a plurality ofconduits each containing one or more conductors therein, cable assembly280 can be similar to assembly 80 in that it can be constructed suchthat portions 288 a-c are constructed only of wires disposed withininsulation. Stated another way, the material forming the wall of conduit288 a may extend between the wires and insulate the wires disposedwithin conduit 288 a from one another.

Although certain exemplary embodiments of flat/round cable assemblieshave been described herein, it should be understood that any cable thattransitions from a flat to round cable can be utilized in percutaneousconnector assemblies 10 and 110 described herein. For example, the cableassemblies are described herein as having a plurality of conductors (orconduits containing such conductors) that are integrally joined along aflat portion of the assembly and separated into individual lengths alonga round portion of the assembly. However, in some embodiments a cableassembly can be alternatively configured such that it includes aplurality of individual conductors (i.e., separate from one another)arranged into flat and round portions, which can be bound together tomaintain their flat and round configurations. In other embodiments, acable assembly may include a plurality of conductors (or conduitscontaining such conductors) integrally joined along their entire lengthsinto a side-by-side flat cable. Such cable can be arranged into a roundportion by rolling or folding the integrally joined conductors anddisposing the rolled or folded cable within a round jacket to maintainthe rounded configuration. Portions of the conductors not within theround jacket can be unfolded or unrolled into a flat portion. Examplesof such cables and other round/flat cables can be found in U.S. Pat.Nos. 4,412,721; 4,973,238; 4,676,891; 6,717,058; 5,201,903; 6,173,101;4,769,906; 6,084,181 and 8,772,636 all of which are hereby incorporatedherein by reference in their entireties.

FIG. 8 depicts a skirt 390 according another embodiment of the presentdisclosure. Skirt 390 is similar to skirt 90 in that skirt 390 may besintered to feedthrough assembly 320. In addition, skirt 390 includesconverging surfaces 397 and 398 extending from feedthrough assembly 320in order to provide rigidity near percutaneous assembly 320 andflexibility far from percutaneous assembly 320. However, unlike skirt90, skirt 390 does not include a peripheral portion of uniformthickness. Rather, surfaces 397 and 398 converge to an edge 399 at aradial extent of skirt 390. Such embodiment has a differentrigidity/flexibility profile than skirt 90 and may be utilized when suchcharacteristics are desired.

FIG. 9 depicts a skirt 490 according to a further embodiment of thepresent disclosure. Skirt 490 is similar to skirt 90 in that skirt 490may be sintered to feedthrough assembly 420. In addition, skirt 490includes converging surfaces 497 and 498 extending from feedthroughassembly 420 and converging to a peripheral portion 492. However, unlikeskirt 90, surfaces 497 and 498 are comprised of plurality of polygonalsurfaces 495 interfacing one another to form a generally conical taperfrom feedthrough assembly 420 to peripheral portion 492. Such embodimenthas a different rigidity/flexibility profile than skirt 90 and may beutilized when such characteristics are desired.

FIGS. 10A and 10B depict a skirt 590 according to yet another embodimentof the present disclosure. Skirt 590 is similar to skirt 90 in thatskirt 590 may be sintered to feedthrough assembly 520. In addition,skirt 590 includes tapered surfaces 597 and 598 extending fromfeedthrough assembly 520 and converging to a peripheral portion 592.However, unlike skirt 90, peripheral portion 592 is a mesh discintegrated into the structure of inner portion 596 by sintering innerportion 596 to mesh disc 592. Such embodiment has a differentrigidity/flexibility profile than skirt 90 and may be utilized when suchcharacteristics are desired.

Although connector assemblies 10 and 110 have been described above inrelation to an MCSD, it should be understood that the herein describedconnector assemblies may be utilized in conjunction with any implantabledevice, such as an implantable renal assist device (IRAD), for example.

In addition, it should be understood that the described magneticinterface between feedthrough assembly 20 and a cap assembly of anexternal device are not essential. Feedthrough assembly 20 can bemechanically connected to a cap or to another component of an externaldevice using other means, such as a threaded connection or taperedmale-female connection.

Furthermore, it should be understood that feedthroughs 40 may havealternative configurations rather than recess 46 to facilitateinterconnection with an external device. For example, feedthroughs 40may extend from feedthrough assembly 20 as an array of pins which arereceivable in conductive openings of a cap assembly.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention. The following paragraphs further describecertain aspects of the invention.

What is claimed is:
 1. A method of forming a percutaneous connectorassembly, comprising: assembling a plurality of conductors adjacent toeach other, each of the plurality of conductors defining a length;coupling a portion of the plurality of conductors to each other alongthe length to define a flat portion of a cable assembly; rearranging afree length of each of the plurality of conductors to define a roundportion of the cable assembly, the round portion being opposite the flatportion of the cable assembly; applying a jacket over the round portionof the cable assembly; and connecting the cable assembly to afeedthrough assembly.
 2. The method of claim 1, further comprisingseparating the plurality of conductors along the length thereof at atransition portion of the cable assembly, the transition portion beingdisposed between the flat portion and the round portion of the cableassembly.
 3. The method of claim 2, further comprising applying thejacket over the transition portion of the cable assembly.
 4. The methodof claim 1, further comprising laminating a plurality of wires with aninsulation material to form the plurality of conductors.
 5. The methodof claim 1, further comprising coupling a crimp to each of the pluralityof conductors and the feedthrough assembly.
 6. The method of claim 1,wherein the feedthrough assembly includes a body having a first endincluding a first end-surface, a second end including a secondend-surface, and a side surface extending between and intersecting thefirst end-surface and the second end-surface, and a plurality ofelectrically conductive feedthroughs extending through the body from thefirst end toward the second end.
 7. The method of claim 6, furthercomprising connecting each conductor of the plurality of conductors to acorresponding electrically conductive feedthrough of the plurality ofelectrically conductive feedthroughs of the feedthrough assembly, theflat portion of the plurality of conductors extending from the body ofthe feedthrough assembly.
 8. The method of claim 1, further comprisingcoupling a skirt to a body of the feedthrough assembly, the skirtextending radially outwardly therefrom.
 9. The method of claim 8,wherein the skirt includes an inner portion having a first surface and asecond surface converging toward each other in a radially outwarddirection.
 10. A method of forming a percutaneous connector assembly,comprising: coupling a first portion of a plurality of conductors toeach other to define a flat portion of a cable assembly; separating theplurality of conductors at a transition portion to define a plurality offree-lengths opposite the flat portion of the cable assembly;rearranging the plurality of free-lengths of the plurality of conductorsto define a round portion of the cable assembly; applying a jacket overthe round portion of the cable assembly; and connecting the cableassembly to a feedthrough assembly.
 11. The method of claim 10, furthercomprising applying the jacket over the round portion and the transitionportion of the cable assembly.
 12. The method of claim 10, furthercomprising covering a plurality of wires with an insulation material toform the plurality of conductors and arranging the plurality ofconductors in a side-by-side configuration.
 13. The method of claim 10,further comprising coupling a crimp to the flat portion of the cableassembly and the feedthrough assembly.
 14. The method of claim 13,wherein the flat portion of the plurality of conductors extends from thefeedthrough assembly.
 15. The method of claim 10, wherein thefeedthrough assembly includes a body having a first end including afirst end-surface, a second end including a second end-surface, and aside surface extending between and intersecting the first end-surfaceand the second end-surface, and a plurality of electrically conductivefeedthroughs extending through the body from the first end toward thesecond end.
 16. The method of claim 10, further comprising coupling askirt to a body of the feedthrough assembly, the skirt extendingradially outwardly from the body and including an inner portion having afirst surface and a second surface converging toward each other in aradially outward direction.
 17. A method of forming a percutaneousconnector assembly, comprising: coupling a plurality of conductors in aside-by-side configuration to form a flat portion of a cable assembly;coupling the plurality of conductors to a plurality of electricallyconductive feedthroughs of a feedthrough assembly, the flat portion ofthe cable assembly extending from the feedthrough assembly; and couplinga skirt to the feedthrough assembly, the skirt including an innerportion having a first surface and a second surface converging towardeach other in a radially outward direction.
 18. The method of claim 17,wherein the feedthrough assembly includes a body having a first endincluding a first end-surface, a second end including a secondend-surface, and a side surface extending between and intersecting thefirst end-surface and the second end-surface.
 19. The method of claim17, further comprising: separating the plurality of conductors at atransition portion to define a plurality of free-lengths opposite theflat portion of the cable assembly; and rearranging the plurality offree-lengths of each of the plurality of conductors to define a roundportion of the cable assembly.
 20. The method of claim 19, furthercomprising applying a jacket over the transition portion and the roundportion of the cable assembly.